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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01927458
Other study ID # M-2012-570-12
Secondary ID
Status Terminated
Phase N/A
First received August 15, 2013
Last updated February 4, 2017
Start date March 2013
Est. completion date December 2015

Study information

Verified date February 2017
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years

- Onset of stroke less than 14 days

- First ischemic stroke causing lower limb weakness (MRC score =4 in knee extensors) and gait impairment

Exclusion Criteria:

- Contraindications to MRI or TMS

- Other neurological disorders

- Significant somatic or psychiatric disorders

- History of seizures

- Language or cognitive disorders prohibiting participation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue

Locations

Country Name City State
Denmark Hammel Neurocenter Hammel

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal gait speed using the 10-m walking test Baseline and follow up immediately following the 4 weeks intervention
Secondary Changes in cortical excitability measures We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation. Baseline
Secondary Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer Baseline and immediately following the 4 weeks intervention
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